Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

This study has been completed.

First Received: September 8, 2005 Last Updated: March 14, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159731

Purpose

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

Condition	Intervention	Phase
Diabetic Peripheral Neuropathy	Drug: Pregabalin	Phase IV

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy

Further study details as provided by Pfizer:

Primary Outcome Measures:

Adverse events

Estimated Enrollment:	160
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with Type 1 or 2 diabetes
Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion Criteria:

Patients must not be in poor or unstable health.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159731

Show 29 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081036
Study First Received:	September 8, 2005
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00159731 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin
Endocrine System Diseases

Pain
Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Anticonvulsants
Diabetes Complications

Additional relevant MeSH terms:

Diabetic Neuropathies
Nervous System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pharmacologic Actions
Neuromuscular Diseases

Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Diabetes Complications

ClinicalTrials.gov processed this record on May 06, 2009